NCT01298765

Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

A 52-Week, Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: BioDelivery Sciences International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

Detailed description

This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic pain. BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.

Conditions

• Pain
• Low Back Pain
• Osteoarthritis
• Neuropathic Pain

Interventions

Type	Name	Description
DRUG	BEMA Buprenorphine	buccal soluble film; applied to the buccal mucosa twice daily

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-02-18
• Last updated: 2018-08-07
• Results posted: 2018-08-07

Locations

26 sites across 1 country: United States